U.S. patent application number 11/243647 was filed with the patent office on 2006-03-30 for means and method for treating an intimal dissection after stent implantation.
Invention is credited to Robert Burgermeister, David R. Fischell.
Application Number | 20060069423 11/243647 |
Document ID | / |
Family ID | 37441571 |
Filed Date | 2006-03-30 |
United States Patent
Application |
20060069423 |
Kind Code |
A1 |
Fischell; David R. ; et
al. |
March 30, 2006 |
Means and method for treating an intimal dissection after stent
implantation
Abstract
If however, the angiography with the contrast medium indicates
that an edge dissection has occurred, then the fixed guidewire
stent delivery catheter would be left in place with its balloon
deflated. The Luer fitting at the proximal end of the stent
delivery catheter would then be cut off and a rescue in the form of
a rescue catheter would be advanced over the stent delivery
catheter. The rescue catheter would then be advanced until its
distal end extended distally beyond the site of the edge
dissection. The fixed wire stent delivery catheter would then be
pulled out of the body through the rescue catheter and a
conventional guidewire would be inserted through the rescue
catheter. The rescue catheter would then be removed leaving the
guidewire in place. A conventional stent delivery catheter would
then be used to deliver a second stent to the site of the intimal
dissection at the edge of the first implanted stent, thus repairing
the dissection.
Inventors: |
Fischell; David R.; (Fair
Haven, NJ) ; Burgermeister; Robert; (Bridgewater,
NJ) |
Correspondence
Address: |
PHILIP S. JOHNSON;JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK
NJ
08933-7003
US
|
Family ID: |
37441571 |
Appl. No.: |
11/243647 |
Filed: |
October 5, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10107221 |
Mar 26, 2002 |
|
|
|
11243647 |
Oct 5, 2005 |
|
|
|
09444104 |
Nov 22, 1999 |
6375660 |
|
|
10107221 |
Mar 26, 2002 |
|
|
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Current U.S.
Class: |
623/1.11 |
Current CPC
Class: |
A61F 2002/9528 20130101;
A61M 2025/0183 20130101; A61F 2/958 20130101; A61F 2/95
20130101 |
Class at
Publication: |
623/001.11 |
International
Class: |
A61F 2/06 20060101
A61F002/06 |
Claims
1. A rescue catheter adapted for placement over a fixed guidewire
stent delivery catheter after an intimal dissection has been
detected following the placement of a stent into an artery of a
human body, the rescue catheter comprising: a guidewire tube having
proximal and distal ends, and a slit snap-on section fixedly
attached near the distal end of the guidewire tube.
2. The rescue catheter of claim 1 wherein the distal end of the
guidewire tube is tapered
3. The rescue catheter of claim 1 wherein the slit snap-on section
has a tapered distal end.
4. The rescue catheter of claim 1 wherein the slit snap-on section
has a tapered proximal end.
5. The rescue catheter of claim 1 wherein the slit snap-on section
has a length of less than 20 centimeters.
6. The rescue catheter of claim 1 wherein the slit snap-on section
has a length of more than 1 centimeter.
7. The rescue catheter of claim 1 further comprising at least one
slit snap-on segment fixedly attached to the guidewire tube at a
location proximal to the slit snap-on section.
8. The rescue catheter of claim 1 wherein the at least one slit
snap-on segment has tapered distal end.
9. The rescue catheter of claim 1 wherein the at least one slit
snap-on segment has tapered proximal end.
10. A method for repairing an intimal dissection resulting from the
placement of a stent that has been delivered from a fixed guidewire
stent delivery catheter, the method comprising the following steps:
a) advancing a fixed guidewire stent delivery catheter into a
stenosed artery of a human subject; b) inflating a balloon placed
at a distal portion of the fixed guidewire stent delivery catheter
so as to deliver a stent mounted onto the balloon into a stenosis
of the stenosed artery; c) deflating the balloon; d) snapping a
slit snap-on section of a rescue catheter having a guidewire tube,
the guidewire tube having a distal end, over the shaft of the fixed
guidewire stent delivery catheter; e) advancing the rescue catheter
until the guidewire tube's distal end lies distal to the observed
intimal dissection; f) advancing a guidewire through the guidewire
tube of the rescue catheter until the guidewire extends beyond the
observed intimal dissection; g) removing the fixed guidewire stent
delivery catheter and rescue catheter from the body of the
patient.
11. The method of claim 10 further comprising the following steps:
pressing the shaft of the fixed guidewire stent delivery catheter
through the slit of the slit snap-on segment.
12. The method of claim 10 further comprising the following steps:
a) placing a stent delivery catheter over the guidewire so that a
stent at a distal portion of the stent delivery catheter is
situated at the site of the intimal dissection; b) delivering the
stent into the intimal dissection so as to repair the intimal
dissection; and c) removing the stent delivery catheter and the
guidewire from the human subject.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of Ser. No.
10/107,221, filed Mar. 26, 2002, which is a continuation of Ser.
No. 09/444,104, filed Nov. 22, 1999, now U.S. Pat. No. 6,375,660,
which is incorporated herein by reference.
FIELD OF USE
[0002] This invention is in the field of catheters used to treat
intimal dissections which result from the placement of a stent into
an artery, such as a coronary artery.
BACKGROUND OF THE INVENTION
[0003] In U.S. patent application Ser. No. 09/444,104, now U.S.
Pat. No. 6,375,660, a stent delivery catheter is described that has
a fixed guidewire at its distal end. Although this system for
delivering a stent into a vessel of the human body has the
advantage of providing an extremely small outside diameter for easy
insertion through even the narrowest of arterial stenoses, it does
not provide for those few cases when an intimal dissection occurs
after stent implantation. Specifically, if a separate guidewire is
used during stent implantation, it can be kept in place after the
stent delivery catheter is removed, thus allowing insertion of a
second stent delivery system over the guidewire to repair any
intimal dissection. However, if the guidewire is fixed to the stent
delivery catheter, it will be removed with the stent delivery
catheter after the stent has been delivered. Without a guidewire
through that portion of the artery where an intimal dissection has
occurred, it can be extremely difficult to place a second stent
delivery catheter to deliver a second stent to repair such an
intimal dissection.
SUMMARY OF THE INVENTION
[0004] The present invention is a rescue catheter that is designed
to be placed over a fixed wire stent delivery catheter after
angiography reveals that an intimal dissection has occurred
typically as an edge dissection either just proximal or just distal
to the stent.
[0005] The present invention is also a method for using such a
catheter to repair an intimal dissection. It should be understood
that an intimal dissection that is in close proximity to the edge
of an implanted stent is called an "edge dissection".
[0006] As previously stated, U.S. patent application Ser. No.
09/444,104 describes a fixed guidewire stent delivery catheter with
an extremely small outside diameter which can be used to deliver a
stent through a very tight arterial stenosis. After the stent on
the stent delivery catheter has been delivered into the arterial
wall, the balloon is deflated and the fixed guidewire stent
delivery catheter would be left in place. Contrast medium would
then be delivered to the site of the dilated stenosis to indicate
if there is any arterial wall dissection. Such an intimal
dissection would typically occur near the proximal or distal edge
of the stent.
[0007] In most cases there will be no edge dissection, the stent
delivery catheter would be removed from the body and the stent
implantation would be considered to be successfully completed.
[0008] If however, the angiography with the contrast medium
indicates that an edge dissection has occurred, then the fixed
guidewire stent delivery catheter would be left in place with its
balloon deflated. The Luer fitting at the proximal end of the stent
delivery catheter would then be cut off and a rescue in the form of
a rescue catheter would be advanced over the stent delivery
catheter. The rescue catheter would then be advanced until its
distal end extended distally beyond the site of the edge
dissection. The fixed wire stent delivery catheter would then be
pulled out of the body through the rescue catheter and a
conventional guidewire would be inserted through the rescue
catheter. The rescue catheter would then be removed leaving the
guidewire in place. A conventional stent delivery catheter would
then be used to deliver a second stent to the site of the intimal
dissection at the edge of the first implanted stent, thus repairing
the dissection.
[0009] Another embodiment of the present invention rescue catheter
is a rapid exchange rescue catheter that is delivered in a manner
similar to a rapid exchange or monorail type angioplasty catheter,
except the guiding device is the fixed wire stent delivery system.
To be most effective and not require cutting of the fixed wire
stent delivery system, the rapid exchange rescue catheter is
designed to "snap onto" the shaft of the fixed wire stent delivery
system where a guidewire tube is attached to the snap on mechanism
and can then be advanced over the fixed wire stent delivery system
until the distal end of the guidewire tube is past the intimal
dissection in the artery. A guidewire is then advanced through the
guidewire tube until it is past the dissection allowing a normal
stent procedure to follow.
[0010] Thus, a rescue catheter is designed to be placed over a
fixed guidewire stent delivery system if angiography indicates that
an intimal dissection has occurred, the rescue catheter being
designed for placement of a conventional guidewire through it so
that a second stent delivery system can be advanced over the
guidewire to deliver a stent to repair the intimal dissection.
Further, this device could be used in the bailout of standard
systems, for instance, in case of guidewire lock-up, such as can
sometimes occur during or after inflation, due to a variety of
reasons, such as balloon inner body collapse
[0011] The rescue catheter treats an intimal dissection created by
the delivery of a stent from a fixed guidewire stent delivery
system.
[0012] Still further, there is provided a rapid exchange rescue
catheter whose distal section is designed to snap onto and be
guided by the shaft of a fixed wire stent delivery system.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 is a side view of a prior art fixed guidewire stent
delivery system shown with the stent mounted onto the balloon.
[0014] FIG. 2 is a longitudinal cross section of the fixed
guidewire stent delivery system with the stent shown delivered into
an arterial stenosis, the balloon is deflated an a distal intimal
dissection has occurred.
[0015] FIG. 3 is a side view of the rescue catheter that is adapted
to pass through an intimal dissection.
[0016] FIG. 4 is a longitudinal cross section of a distal portion
of the rescue catheter at section 5-5 of FIG. 4.
[0017] FIG. 5 shows the rescue catheter placed over the fixed
guidewire stent delivery system and through an intimal
dissection.
[0018] FIG. 6 shows the rescue catheter in place with the stent
delivery system removed and a conventional guidewire placed through
the rescue catheter with its distal end placed beyond the intimal
dissection.
[0019] FIG. 7 shows the guidewire in place and the rescue catheter
removed.
[0020] FIG. 8 shows another embodiment of the present invention
rescue catheter having an open distal end.
[0021] FIGS. 9A and 9B illustrate a first snap-on embodiment of the
present invention rescue catheter.
[0022] FIGS. 10A and 10B illustrate a second snap-on embodiment of
the present invention rescue catheter having a tapered distal
snap-on section for improved slideability.
DETAILED DESCRIPTION OF THE INVENTION
[0023] FIG. 1 is a side view of a prior art stent delivery system 1
having a fixed guidewire 6 attached to the distal end of a balloon
4 onto which a stent 5 has been mounted. A shaft 2 which extends
for most of the length of the stent delivery system 1 is attached
at its distal end to the balloon 4 and at its proximal end to a
Luer fitting 3. This type of stent delivery system is described in
detail in U.S. patent application Ser. No. 09/444,104, incorporated
herein by reference. If angiography indicates that there has been
an intimal dissection after the stent 5 is placed into an arterial
stenosis, the Luer fitting 3 is cut off from the shaft 2 so that a
rescue catheter can be advanced over the stent delivery system
1.
[0024] FIG. 2 illustrates the delivered stent 5' deployed into an
artery with a deflated balloon 4' attached at its distal end to the
guidewire 6 and at its proximal end to the shaft 2. A core wire 9
attached to the fixed guidewire 6 can extend to the proximal end of
the stent delivery system 1.
[0025] FIG. 3 is a side view of a rescue catheter 10 having a shaft
12 that extends for most of its length, an interior lumen 18 and a
distal cone 11 located at a distal portion of the catheter 10. The
shaft 12 has an elongated slit 14 whose distal end 17 is situated
between 0.5 and 20 cm from the proximal end of the cone 11. The
cone 11 has a hole at its distal end and at least one slit 15 that
extends to and possibly beyond the distal end of the shaft 12. The
length of the cone 11 should be less than 10 cm and optimally
approximately one cm. The length of the cylindrical shaft 12 should
be at least 100 cm and optimally longer than 125 cm. The inside
diameter of the shaft 12 should be just slightly larger than the
maximum outside diameter of the stent delivery system 1.
[0026] FIG. 4 is a longitudinal cross section of a distal portion
of the catheter 10 showing the distal cone 11, the shaft 12, the
distal opening 13, a slit 15 and the lumen 18. Although the slit 15
is shown extending into the shaft 12, it is envisioned that its
proximal end could remain within the cone 11 or it could extend for
as much as a centimeter into the shaft 12. Furthermore, it should
be understood that there could be as many as four slits 15 around
the circumference of the cone 11 or as few as one.
[0027] FIGS. 5, 6 and 7 illustrate how the present invention would
be used to place a conventional guidewire through an intimal
dissection that extends beyond the edge of a stent. FIG. 5 shows
the catheter 10 inside an artery into which the stent 5' has been
deployed. If there is an intimal dissection 8 extending beyond the
edge of the stent 5', it can be detected by the interventional
cardiologist using contrast medium. After an intimal dissection is
detected, the Luer fitting 3 is cut off from the shaft 2 of the
stent delivery system 1. The interventional cardiologist would then
open the cone 11 and place it over the cut off proximal end of the
shaft 2 of the stent delivery system 1. The interventional
cardiologist would then advance the catheter 10 over the shaft 2
until the proximal end of the shaft 2 could be pulled out of the
slit 14. While holding the proximal end of the shaft 2 in one hand,
the interventional cardiologist would, with his other hand, advance
the catheter 10 over the stent delivery system I until the opening
13 of the cone 11 was advanced over the guidewire 6 and past beyond
the intimal dissection 8. Because of its conical shape, and because
the inside diameter of the end hole 13 would be approximately the
same as the outside diameter of the guidewire 6, the distal end of
the catheter 10 should readily pass through the dissection 8. Since
it is expected that the diameter of the guidewire 6 would be 0.014
inches, an optimal diameter for the opening 13 of the cone 11 would
be approximately 0.014 inches.
[0028] After the catheter 10 is positioned as shown in FIG. 5, the
stent delivery system I is pulled back out of the catheter 10 and
out of the patient's body. A conventional guidewire 17 is then
inserted through the catheter 10 until its distal end lies distal
to the intimal dissection 8. this condition is shown in FIG. 6. The
catheter 10 is then removed from the patient's body and the
guidewire 17 remains in place as shown in FIG. 7. Because of the
slit 14 in the side of the shaft 12 of the rescue catheter 10, a
conventional length of approximately 135 cm (and even up to 300 cm)
could be used for the guidewire 17. An alternative method would be
to use a guidewire 17 that is somewhat more than twice as long as a
conventional guidewire.
[0029] FIG. 8 shows another embodiment of the present invention
rescue catheter 50 having an open distal end 56 and central lumen
53. The catheter 56 has a distal cylindrical section 52 of length
L' and a proximal section 55 with a slit 54 that extends from the
proximal end 58 of the catheter 50 to a widened opening 59 at the
distal end of the slit 54 which is the proximal end of the distal
section 52. The length L' is typically between 0.5 and 20
centimeters.
[0030] Similar to the rescue catheter 10 of FIGS. 4 through 7, the
rescue catheter 50 can be advanced over the cut off proximal end of
the stent delivery system 1. The rescue catheter 50 can either be
advanced concentrically over the stent delivery system 1 in an
"over-the-wire" type delivery or the rescue catheter 50 can be used
in a rapid exchange method where only the distal section 52 is
advanced concentrically over the stent delivery system 1. Thus the
shaft of the stent delivery system 1 would lie inside the rescue
catheter 50 only between the distal end 56 and the opening 59.
Ideally as the rescue catheter 50 is advanced, more and more of the
shaft of the stent delivery system 1 can be pressed inside of the
proximal section 55 through the slit 54. Once the rescue catheter
50 has been advanced distally to the desired location, the stent
delivery system 1 can be retracted through the lumen 53 of the
rescue catheter 50. A guidewire can then be advanced through the
lumen 53 to provide guidance for additional recannalization
devices.
[0031] FIG. 9A illustrates a first snap-on embodiment of the
present invention rescue catheter 60 having a guidewire tube 64 of
length L1 and distal end 65 with slit snap-on section 62 having
length L2. L1 must be sufficiently long so that the distal end of
the catheter 60 can reach the desired point in the human vascular
system and is typically between 1 and 2 meters. L2 is typically
between 0.5 and 20 centimeters.
[0032] FIG. 9B shows an enlargement of the distal end 65 of the
rescue catheter 60 of FIG. 9A. The distal end 65 includes the slit
snap-on section 62 with lumen 69 and slit opening 66. Also shown in
FIG. 9B is the lumen 67 and tapered distal end 63 of the guidewire
tube 64. The tapered distal end 63 facilitates penetration through
a vascular obstruction such as an intimal dissection. Unlike the
rescue catheters 10 and 50 of FIGS. 3 and 8, the rescue catheter 60
does not require that the fitting at the proximal end of the stent
delivery system 1 be cut off. The slit snap-on section 62 is
designed to be snapped onto the shaft 2 of the stent delivery
system 1 of FIGS. 1 and 2. This is done by pressing the shaft 2
through the slit 66 until the shaft 2 snaps into the lumen 69 of
the slit snap-on section 62. The rescue catheter can be advanced
over the shaft 2 and beyond until the distal end 63 of the
guidewire tube 64 lies beyond the vascular obstruction. A guidewire
can than be advanced through the lumen 67 of the guidewire tube 64
until the distal end of the guidewire lies beyond the vascular
obstruction. The rescue catheter 60 and stent delivery system I can
then be removed from the body and the guidewire can be used to
perform additional procedures such as stent delivery, to
recannalize the vessel.
[0033] FIG. 10A illustrates a second snap-on embodiment of the
present invention rescue catheter 70 having a guidewire tube 74 of
length L3 with guidewire lumen 71. The catheter 70 also has a
distal end 80 with tapered slit snap-on section 82 having length
LA. L3 must be sufficiently long so that the distal end of the
catheter 70 can reach the desired point in the human vascular
system and is typically between 1 and 2 meters. L4 is typically
between 0.5 and 20 centimeters. The rescue catheter 70 also has
additional slit snap-on segments 77 and 79 where the slit snap-on
segment 77 lies a distance L5 proximal to the proximal end of the
slit snap-on section 82 and the slit snap-on segment 79 lies a
distance L6 proximal to the proximal end of the snap-on segment 77.
The distances L5 and L6 can be as short as 1 cm or as long as a
meter.
[0034] Although the rescue catheter 70 has two slit snap on
segments 77 and 79, it is envisioned that it could have no slit
snap-on segments such as the rescue catheter 60 of FIGS. 9A and 9B
or it could have any number from 1 to 100 of the slit snap-on
segments. The slit snap-on segments improve the delivery of the
rescue catheter 70 by keeping the guidewire tube 74 in close
proximity to the shaft 2 of the stent delivery system 1 of FIGS. 1
and 2.
[0035] It is also envisioned that the slit snap-on segments 77 and
79 can be tapered similar to the distal slit snap-on section 82.
While the slit snap-on segments 77 and 79 are shown in FIG. 10A as
being relatively short compared to the distal slit snap-on section
82, it is envisioned that the slit snap-on segments 77 and 79 can
be of equal or greater length than the distal slit snap-on section
82.
[0036] FIG. 10B shows an enlargement of the distal end 80 of the
rescue catheter 70 of FIG. 10A. The distal end 80 includes the
tapered slit snap-on section 82 with lumen 89 and slit opening 86.
The tapered slit snap-on section 82 has a tapered distal end 84 and
a tapered proximal end 88 which facilitate penetration through a
vascular obstruction and improved delivery over the stent delivery
system of FIGS. 1 and 2.
[0037] Also shown in FIG. 10B is the tapered distal end 73 of the
guidewire tube 74 which facilitates penetration through a vascular
obstruction such as an intimal dissection. Unlike the rescue
catheters 10 and 50 of FIGS. 3 and 8, the rescue catheter 70 does
not require that the fitting at the proximal end of the stent
delivery system I be cut off. The tapered slit snap-on distal
section 82 is designed to be snapped onto the shaft 2 of the stent
delivery system I of FIGS. I and 2. This is done by pressing the
shaft 2 through the slit 86 until the shaft 2 snaps into the lumen
89 of the slit snap-on section 82. The rescue catheter can then be
advanced over the shaft 2 and beyond until the distal end 73 of the
guidewire tube 74 lies beyond the vascular obstruction. A guidewire
can than be advanced through the lumen 71 of the guidewire tube 74
until the distal end of the guidewire lies beyond the vascular
obstruction. The rescue catheter 70 and stent delivery system 1 can
then be removed from the body and the guidewire can be used to
perform additional procedures such as stent delivery, to
recannalize the vessel. Although both proximal end 88 and distal
end 84 of the slit snap-on section 82 are tapered, it is envisioned
that only one of the ends 88 and 84 or neither of the ends 88 and
84 need be tapered.
[0038] Various other modifications, adaptations, and alternative
designs are of course possible in light of the above teachings.
Therefore, it should be understood at this time that within the
scope of the appended claims, the invention may be practiced
otherwise than as specifically described herein.
* * * * *